MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 36IDX60OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121936160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Sep 22, 2017: pfs and medical records received.After review of the medical records for the mdr reportability, it was stated that after patient's revision, patient had experienced pain and trochanteric bursitis.There is no revision reported at this time.
Additional Manufacturer Narrative
Udi: (b)(4).
Additional Manufacturer Narrative
(b)(4).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 will be filed as appropriate.
Additional 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 will be filed as appropriate.
Event or Problem Description
Complaint description: sep 22, 2017: pfs and medical records received.After review of the medical records for the mdr reportability, it was stated that after patient's 1st revision (b)(6) 2008), patient had experienced pain and trochanteric bursitis.There is no 2nd revision reported at this time.Update sep 22, 2017 reviewed records for reportability.Identified that during revision surgery (b)(6) 2008, surgeon explanted s-rom stem (leaving the s-rom sleeve) and replaced it with another stem.There is no record of this new stem on the implant record for (b)(6) 2008, but it is clearly noted in the or revision operative note.Added an unknown s-rom stem for alleged pain.Complaint updated on: oct 20, 2017 / | investigation method: / | investigation summary:.

• Brand Name: PINN MAR +4 10D 36IDX60OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6964008
• Report Number: 1818910-2017-26919
• Device Sequence Number: 11150399
• Product Code: LPH
• UDI-Device Identifier: 10603295014614
• UDI-Public: 10603295014614
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2013
• Device Catalogue Number: 121936160
• Device Lot Number: CA8A91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 06/15/2018; 11/01/2018; 07/31/2019
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 06/28/2018; 11/02/2018; 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 57