MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR FEM IMPLANT SZ 49; HIP METAL FEMORAL HEADS

Catalog Number 999890049

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Muscle Weakness (1967); Muscular Rigidity (1968); Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); No Code Available (3191); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Litigation papers allege pain, stiffness, discomfort, weakness and excessive metal ion levels.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.Udi: unavailable.  this complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.  a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: wwcapa 00780 superseded by mdd capa-001226 was established regarding root cause and/or corrective actions.Reference: mdd capa-001226.

Event Description

Litigation papers allege pain, stiffness, discomfort, weakness and excessive metal ion levels.Litigation complaint received ad 27 dec 2023.Patient was revised was due to severe pain and discomfort, increased metal levels in blood including cobalt and chromium; permanent injuries, emotional distress, disability, disfigurement; economic damages including medical and hospital expenses for revision surgery followed by monitoring, rehabilitation and pharmaceutical costs.Doi:(b)(6) 2007.Dor: (b)(6) 2023.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

During the operation, there was a copious amount of dark gray to brown fluid.This was to be based on the mri where the patient had several large cysts which appeared to be full of metalogic tissue secondary to abnormal wear from asr design.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Update: 2-feb-2024 update 1-feb-2024 received did not have any additional details to be added in investigation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: DEPUY ASR FEM IMPLANT SZ 49
• Type of Device: HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4635906
• MDR Text Key: 5613257
• Report Number: 1818910-2015-17314
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2011
• Device Catalogue Number: 999890049
• Device Lot Number: 1122191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 56; DEPUY ASR FEM IMPLANT SZ 49; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL SLEEVE ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male