MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882748

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)

Event Date 08/12/2022

Event Type  Injury  

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.

Event Description

Due to broken inlay (h-tep (b)(6) 2018 on the right side / pinnacle corail -> revision operation necessary (head and inlay change, as well as debridements).

Event Description

Claim alleges the patient suddenly felt incredible pain in the right hip while walking.It was found out that the implants was broken into several pieces without external influences.Patient had revision due to a broken liner and head.Clinical visit reported squeaking and cracking with crepitation hip.X-ray shows an inlay fracture.Patient also experienced a limited range of motion.

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.H10 additional narrative: e3 initial reporter occupation: lawyer.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: 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 was performed, for the finished device [121882748/8683272] number.And no non-conformances/manufacturing irregularities were identified.

• Brand Name: DELTA CER INSERT 32ID X 48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• 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: 15587067
• MDR Text Key: 301561344
• Report Number: 1818910-2022-20163
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 121882748
• Device Lot Number: 8683272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/22/2022; 11/09/2022
• Supplement Dates FDA Received: 11/04/2022; 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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: APEX HOLE ELIM POSITIVE STOP; CORAIL AMT COLLAR SIZE 9; DELTA CER HEAD 12/14 32MM +1; PINNACLE 100 HA ACET CUP 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female