MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-052

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2023

Event Type  Injury  

Event Description

Total hip revision.Liner was completely worn out from one side.Primary operation was (b)(6) 2018.Surgeon commented that the cup itself was upright too much so on wrong position.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 60.Action taken when event occurred? worn implant were taken out.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences? was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Other information: n/a.Is the patient part of a clinical study? unknown.(b)(4).Device property of: none.Device in possession of: none.

Manufacturer Narrative

Product complaint # (b)(4).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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed wear condition on the inner surface of the acetabular cup.Based on the observations of the involved devices it is reasonable to conclude that the poly liner has disassociated from the cup, however, mispositioned allegation could be not confirmed since x-ray evidence was not provided.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE 100 ACET CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17046760
• MDR Text Key: 316398982
• Report Number: 1818910-2023-11341
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008552
• UDI-Public: 10603295008552
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-01-052
• Device Catalogue Number: 121701052
• Device Lot Number: 8841458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 07/19/2023
• Supplement Dates FDA Received: 06/16/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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: ALTRX NEUT 36IDX52OD.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female