MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-01-08 for OPTIPAC 60 REFOBACIN BONE CEMENT R 4711500396-1 manufactured by Biomet France S.a.r.l..
[174101637]
(b)(4). Report source, foreign: event occurred in (b)(6). Medical product : cpt hip system femoral stem 12/14 neck taper standard offset size 1 130mm stem length, reference 00811400100, lot 63735436, investigated in (b)(4). Versys hip system femoral head 12:14 taper 22mm diameter +3. 0 neck length, reference (b)(4), batch 63677745, investigated in (b)(4). Avantage cemented acetabular cup size 48, reference (b)(4), batch 0001105980, investigated in (b)(4). Advantage cemented inlay s48, reference(b)(4), batch 0001102705 investigated in (b)(4). Optipac-s 60 refobacin bone cement r, reference (b)(4), batch b708c05355, investigated in (b)(4). The device was not returned to the manufacturer. Therefore it could not be analyzed and the event couldn't be confirmed. The review of the device manufacturing quality record indicates that 926 products optipac-s 60 refobacin bone cement r, reference (b)(4), batch a710b05615 were manufactured on 16th march 2017. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. No non conformity or deviation was observed which could be linked to the event described in the complaint. Within one year, only the current complaint has been recorded for optipac-s 60 refobacin bone cement r, reference (b)(4), batch a710b05615 regarding a dislocation. According to available data, the exact root cause can? T be determined. This complaint could be reopened if further information is received later.
Patient Sequence No: 1, Text Type: N, H10
[174101638]
It was reported that an initial left total hip arthroplasty was performed with implantation of an advantage cemented shell? 48mm, advantage inlay s48, optipac-s 60 refobacin bone cement lot a710b05615 and lot b708c05355, femoral stem 12/14 and femoral head sterile 12/14 on (b)(6) 2017. Subsequently, the patient was revised on (b)(6) 2018 due to recurrent dislocations, instability, and impingement. During the revision, a hematoma was noted as well as an absent posterior joint capsule. The advantage cemented shell? 48mm was left in place. The stem and femoral head were replaced with a competitor product, and the bearing was replaced by the advantage inlay s48 / 28. This report is a split of the (b)(4). The initial medwatch report number 3006946279-2019-00380 was submitted on august, 30 2019 and was common to the cup, the bearing and the two optipac. This follow up report provide the investigation for the optipac batch a710b05615.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00546 |
| MDR Report Key | 9563172 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-11 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2019-11-19 |
| Device Manufacturer Date | 2017-03-16 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET FRANCE S.A.R.L. |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 26903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIPAC 60 REFOBACIN BONE CEMENT R |
| Generic Name | BONE CEMENT, ANTIBIOTIC |
| Product Code | MBB |
| Date Received | 2020-01-08 |
| Catalog Number | 4711500396-1 |
| Lot Number | A710B05615 |
| Device Expiration Date | 2018-08-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-08 |