MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Difficult to Insert (1316); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Distress (2329); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

(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.Initial reporter occupation: lawyer.(b)(4).

Event Description

Asr litigation records received.Litigation alleges injury, elevated chromium and cobalt levels, economic loss, pain, suffering, and emotional distress.Doi: (b)(6) 2007; dor: (b)(6) 2019; 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 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.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, the patient was revised due to failed right thr and pain.It was also indicated that there was a surgical delay of 3 hours due to the fact that a well-fixed femoral stem had to be removed that required complex intraoperative decision making.Operative notes reported that it was apparent during reduction of the hip that the femoral head was actually moving on to the trunnion.There was marked metal debris in this region and fair amount of metallic looking fluid was encountered.The trunnion was worn in both lateral and anterior-posterior direction.Metallic debris and but necrotic tissues were removed.Doi: (b)(6) 2007, dor: (b)(6) 2019, right hip.

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.Device history lot : there is no evidence suggesting manufacturing or material error as a potential cause for the incident involving the asr platform.Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.Added: d6a, d6b corrected: h6 (clinical code).

Event Description

Medical records were received: patient was revised due to constant pain that was preventing everyday task, including sleep, also developed a bad limp.Leg pain and problems with right knee.Hip malfunction in april 2018.6-8 months before surgery, right knee felt like it was out of alignment and it was very painful to walk, after 10-15 minutes it would calm down for me to be able to walk again.Starting january 2020, started having pains on the pelvic area pain was so great, he couldn't sneeze, cough, and hard to get out of the chair at times.

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: a4, b5, b7, e1, h6 (clinical code).Corrected: d1, d2a, d2b, d4 (catalog), e1.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: 10699345
• MDR Text Key: 212085774
• Report Number: 1818910-2020-22781
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/05/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 07/26/2024; 08/01/2024
• Supplement Dates FDA Received: 01/19/2021; 07/30/2024; 08/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.; ASR.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 109 KG