MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 22X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-22-190
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Operation was going well.Surgeon had selected desired implants.Implants opened the taper protector cover was impossible to remove from the stem, the surgeon used several different methods to remove from gently trying to prise it off to brute force and even slicing through it with a scalpel.The cover was impossible to remove.The item will be available for investigation once it has been decontaminated.The operation was delayed for 15 mins, there was no harm to the patient.Another same sized stem was available.And the case proceeded without further issue.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: there were 2 holds and an nr for foreign matter.The parts were reworked to meet the listed specifications.There was a hold for the rework routing missing a component.The issue was resolved and the order completed.No other deviations or anomalies were observed.

• Brand Name: RECLAIM DISTAL TAPERED 22X190A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11579306
• Report Number: 1818910-2021-06253
• Device Sequence Number: 4206121
• Product Code: KWA
• UDI-Device Identifier: 10603295077336
• UDI-Public: 10603295077336
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/25/2021

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 Expiration Date: 06/30/2021
• Device Model Number: 1977-22-190
• Device Catalogue Number: 197722190
• Device Lot Number: E72KNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 04/15/2021; 05/26/2021; 05/27/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 03/31/2021; 04/20/2021; 05/26/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR