MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR BANTAM 10D 22.225X46 LINER; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Model Number	1245-46-503
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the duraloc enduron liner is worn.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Questions: a.Did the event happen during primary surgery or revision surgery? primary surgery b.If this happens during revision, please provide the date of revision.Na c.Was the patient experiencing any adverse symptoms that led to the revision surgery? no d.Can you confirm the primary surgery date or the original implantation date? unknown e.Was there a surgical delay because of this event? if yes, what is the duration of the delay? no f.Can you confirm the name of the hospital/account name? (b)(6).G.Affected side? left h.Kindly provide the date of event.This complaint was received on 02/01/2022.Date of notification: 01/01/2022.Answers: please could you let me know if any/none of this information is available: - 1.Product details - lot numbers and / or product codes ref: (b)(4).Lot: unknown 2.Radiographs/x-ray films please provide all x-rays relevant to the reported event for example - pre-operative, post primary, pre-revision and intervening time points.-> not available 3.Patient demographics the following are the types of patient demographics we require: - relevant comorbidities, date of implantation, date of revision, operative side, age at the time of the procedure, weight, height, and activity level.-> unknown 4.Excerpts from the clinical correspondence:- please provide all correspondence relevant to the reported event for example: - onset of symptoms, trauma, other devices, leg length discrepancy, gait patterns, medical investigations or any other issues the complainant feels important.No adverse symptom 5.Implant insertion op notes:- not available.
Additional 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.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: d10 and e1 (initial reporter facility name).

• Brand Name: DUR BANTAM 10D 22.225X46 LINER
• Common Device Name: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13542370
• Report Number: 1818910-2022-02918
• Device Sequence Number: 17077157
• Product Code: LPH
• UDI-Device Identifier: 10603295019008
• UDI-Public: 10603295019008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1245-46-503
• Device Catalogue Number: 124146526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 04/05/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/25/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURALOC BANTAM ACET CUP 46 OD
• Patient Sex: Unknown