MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Material Disintegration (1177); Material Deformation (2976)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/21/2017

Event Type  Injury  

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 Description

Litigation records of pinnacle received. Litigation alleges pain, suffering, disability, irritation and discomfort. Doi: (b)(6) 2008- dor: (b)(6) 2017 (right hip).

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 Description

Pfs and medical records received. In addition to what were previously alleged, pfs alleges limited mobility, walking difficulty, loss of sexual activity and depression. After the review of medical records, it was reported that the patient was revised to address metallosis as indicated by the aspirated serous brown fluid, elevated metal ions and tissue necrosis due to metal debris. Revision notes reported metallosis along the stems¿s trunnion. Clinical notes also reported soreness. There are no lab results provided. Added stem due to reported elevated metal ions. In addition to what was previously alleged, ppf alleges elevated metal ions, metallosis, and metal wear. After review of medical record for mdr reportability, patient was revised to address mechanical complications status post right total hip arthroplasty. Revision notes reported that a femoral head was dislocated and was removed. There was noted to be some metallosis along the trunnion of the stem. There was a scalloped markings in the cup.

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. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.  .

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7898981
• Report Number: 1818910-2018-70099
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 62 YR
• Patient Weight: 132
• Patient Outcome(s): Required Intervention