MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 58; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800758

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation record received.Litigation alleges that patient experienced progressive chronic hip pain, impaired ability to perform normal daily activities even work, suffering, lost of income, economic and personal damages, atrophy in thigh muscles, elevated metal ion, and decrease mobility.Doi: (b)(6) 2007 - dor: (b)(6) 2019, (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: h5, h7, h9.

Event Description

Additional information received in addition to what previously alleged, pfs alleges tightness, squeaking and bursitis.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

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: added: a2 (date of birth and age), b5, b7, d4 (lot #, udi and expiration date), d6b, g2, g4 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records patient was revised to addressed failed left total hip arthroplasty with loose femoral component and has evidence of toggle with any pressure on the stem, vertically oriented and increased acetabular inclination with minimal metallosis.

• Brand Name: ASR ACETABULAR CUPS 58
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10368958
• MDR Text Key: 201766088
• Report Number: 1818910-2020-17633
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2011
• Device Catalogue Number: 999800758
• Device Lot Number: 2206549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2006
• 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: ADAPTER SLEEVES 12/14 +2; ASR UNI FEMORAL IMPL SIZE 51; CORAIL2 STD SIZE 13; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 95 KG