MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; HIP FEMORAL STEM

Model Number 1570-11-120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Depression (2361); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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 complaint received ad 17 oct 2022.Patient was revised was due to pain, discomfort, increased metal levels in blood including cobalt and chromium, permanent injuries, emotional distress, disability, disfigurement and economic damages.Doi: (b)(6) 2007; dor: (b)(6) 2022; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint (b)(4) investigation summary
=
> 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.H10 additional narrative: added: a2, b5, b7, d4 (lot, catalog, udi), g4 (pma/ 510(k)), h4, h6 health effect - clinical code corrected: d1, d2a, d10 (concomitant med products).

Event Description

Medical records received.The patient verbalized uncertainty the exact date when the symptoms began.The patient experienced inability to walk, limp, neck and back pain was aggravated.Anxiety and depression about the uncertainty of not knowing what could happen were also manifested.The feeling of constant nervousness leads to losing weight and sleeplessness.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15707617
• MDR Text Key: 302763949
• Report Number: 1818910-2022-21690
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1570-11-120
• Device Catalogue Number: 157011120
• Device Lot Number: BV9FV1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/04/2022; 12/19/2022
• Supplement Dates FDA Received: 11/04/2022; 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 52; ASR UNI FEMORAL IMPL SIZE 46; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female