MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.*NONPOROUS STEM #2; PFC HIP STEM AND LINER IMPLANTS : HIP FEMORAL STEM

Catalog Number 853612

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

Patient Problem No Code Available (3191)

Event Date 10/15/2020

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

Surgeon planned for a right hip revision of a (b)(6) yrs old female.Patient had a p.F.C.Cemented hip, a pfc cup, pfc liner, 28+0 head and 2 screws.All removed and replaced with a revision.Had we been able to source a replacement pfc acetabular liner and all 28 and 32 pfc head options, this surgery would have taken 30 minutes instead of 4 hours.The surgeon was aware of the limited availability and his plan a if everything went well was just to change the pfc head with a 32+0 option (only one available) and a multi hole gription cup with a 32 altrx liner.However, patient was more unstable than expected so the surgeon removed the stem&cement, removed cup, liner, screws and head.Replaced with a stryker dm cup and a long cemented exeter.

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.No code available (3191) is used to capture surgery prolonged.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.Provided images have been reviewed.Nothing indicative of a product problem is identified.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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: d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: PFC HIP STEM AND LINER IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10756546
• MDR Text Key: 213717991
• Report Number: 1818910-2020-23569
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K900638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/15/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 853612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 02/02/2021; 02/25/2021
• Supplement Dates FDA Received: 11/10/2020; 02/19/2021; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12MM NON-POROUS DISTAL CENTRAL; LCS COMP RP AOX INS STD+ 15; P.F.C.* 28MM HEAD +0MM; P.F.C.*LINER 48-52/10DEG-28; PFC*POR SHELL/MULTIHOLE SZ50MM; UNK CEMENT RESTRICTOR/PLUG; UNK HIP BONE SCREW; UNK HIP BONE SCREW; 12MM NON-POROUS DISTAL CENTRAL; LCS COMP RP AOX INS STD+ 15; P.F.C.* 28MM HEAD +0MM; P.F.C.*LINER 48-52/10DEG-28; PFC*POR SHELL/MULTIHOLE SZ50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR