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

Model Number 1218-87-352

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

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.(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

The patient made an appointment to his doctor after noticing a bump on his thigh.During the surgery, pseudotumors were removed.

Event Description

After review of medical records patient was revised to addressed bilateral hip mechanical failure of total hip arthroplasty with pseudotumor formation from metal on metal.There was some corrosion between the head and trunnion.This was cleaned using a sponge and irrigation.

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: added: b5, b7, d4 (expiration date) and d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8197714
• MDR Text Key: 131440935
• Report Number: 1818910-2018-79167
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 1218-87-352
• Device Catalogue Number: 121887352
• Device Lot Number: 3028930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Patient Sequence Number: 1
• Treatment: ASPHERE M SPEC 12/14 36 +8.5.; PINNACLE SECTOR II CUP 52MM.; TRI-LOCK BPS SZ 5 HI OFFSET.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 100