MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN DEPUY ASR HEAD; HIP FEMORAL HEAD

Catalog Number UNK-ASR

Device Problems Corroded (1131); Nonstandard Device (1420); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Irritation (1941); Pain (1994); Local Reaction (2035); Synovitis (2094); Discomfort (2330)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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.

Event Description

Jun 05, 2017: litigation received.Litigation alleges pain, swelling, inflammation, and damage to surrounding bone and tissue, spread of metal throughout the body and lack of mobility.It also alleges that these symptoms were the result of possible loosening of the implant, fracture of bone around implant, dislocation or spread of metal debris from the head and cup rubbing and rotating against each other.There were no medical records for the alleged loosening, fracture, dislocation and metal debris.Shall there be new information received , this complaint will be updated.

Manufacturer Narrative

(b)(4).

Event Description

Update jun 26, 2017: der received.It was stated that patient underwent removal of asr.Product codes and lot numbers were provided.Added sleeve to the complaint.No other information at this time.This complaint was updated on jul 7, 2017.

Event Description

Update aug 7, 2017: medical records received.After review of the medical records for mdr reportability, there is no new information.This complaint was updated on: aug 21, 2017.

Manufacturer Narrative

No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After the review of medical records for mdr reportability, it was stated that the patient was revised to address pain, elevated metal ions, and large fluid collection.Revision notes reported large pseudocapsule, grey/black tissue consistent with adverse soft tissue response to metal wear debris, defect in the posterior capsule of the hip, and corrosion on the trunnion.

Manufacturer Narrative

Additional narrative: litigation received.Litigation alleges pain, swelling, inflammation, and damage to surrounding bone and tissue, spread of metal throughout the body and lack of mobility.It also alleges that these symptoms were the result of possible loosening of the implant, fracture of bone around implant, dislocation or spread of metal debris from the head and cup rubbing and rotating against each other.There were no medical records for the alleged loosening, fracture, dislocation and metal debris.Shall there be new information received, this complaint will be updated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY ASR HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6687069
• MDR Text Key: 79069796
• Report Number: 1818910-2017-20537
• Device Sequence Number: 0
• Product Code: KWL
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-ASR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR