MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121701048

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

(b)(6) 2021: patient underwent a right total hip replacement.(b)(6) 2023: patient underwent a right hip revision due to pain, feeling of shifting, and grinding/crepitus.X-rays showed anterior subluxation of the femoral head.Intra-op the polyethylene had disassociated from the shell and head was abrading on the anterior aspect of the acetabular shell.Post-op note also indicated the polyethylene liner was broken.The cup, liner and femoral head were revised.Doi: (b)(6) 2021 dor: (b)(6) 2023 affected site: right hip.

Manufacturer Narrative

Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 121701048 / lot j17y14 combination.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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 121701048 / lot j17y14 combination.

• Brand Name: PINNACLE 100 ACET CUP 48MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18954008
• MDR Text Key: 338305730
• Report Number: 1818910-2024-06299
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008538
• UDI-Public: 10603295008538
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121701048
• Device Lot Number: J17Y14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ACTIS COLLARED STD SIZE 3; ALTRX +4 NEUT 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female