MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; HIP METAL ACETABULAR LINERS

Catalog Number 121887352

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348); Test Result (2695)

Event Date 03/09/2017

Event Type  Injury  

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.

Event Description

Left hip arthroplasty on (b)(6) 2011.In (b)(6) 2017 the patient was subjected to a revision surgery due difficulty in walking, feeling of instability.In addition high ions levels of cr and co were detected.Update (b)(6) 2017: claim notification, litigation and medical records of pinnacle received.In addition to what was previously alleged,claim letter alleges pain, noise(scratching and tearing) and bone erosion.(b)(6) 2011; (b)(6) 2017 (left hip) pinnacle.

Manufacturer Narrative

Pc(b)(4).No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).Investigation summary
=
> no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7153981
• MDR Text Key: 96021730
• Report Number: 1818910-2017-52702
• Device Sequence Number: 1
• Product Code: OVO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P090002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887352
• Device Lot Number: 3081064
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2021
• Date Device Manufactured: 02/22/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR