MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MAR LNR L 32MM+3MM 10 DEG; S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1220-72-332
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A review of provided x-ray images is unable to identify and allegations associated with the acetabular liner.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).
Event or Problem Description
Clinical adverse event received for poorly positioned acetabular component : abnormal radiographic evaluation event is serious and is considered moderate.Event is definitely related to device and is definitely not related to procedure.Medical records received on 31 jul 2020 and 3 aug 2020 were reviewed to identify patient harms/product issues.On (b)(6) 2003, the patient underwent a a right hip revision involving the removal of an unknown hip due to pain, poly wear, and osteolysis.A depuy s-rom 60 mm deep profile +6 ztt cup, with two dome screws and one rim screw, along with one rim pin, and a 32 mm inner diameter 10 degree posterior-lipped +3 lateralized depuy liner were implanted.On the femoral side, howmedica product was implanted.On (b)(6) 2014, the patient underwent a right hip revision due to a worn, fractured, and dislocated liner.The patient was also experiencing grinding and instability.The surgeon noted slight wear on the depuy cup and minimal lysis.The cup was well ingrown and not revised.An s-rom lipped liner was implanted with one locking screw and one locking pin.The surgeon indicated the cup had minimal anteversion, but felt the cup gave the patient good stability with the newly implanted liner.Event is captured on (b)(4).On (b)(6) 2020, the patient presented for a right hip evaluation due to audible popping/clunking, audible and palpable subluxation, possible early osteolysis, poorly positioned cup, and instability.The surgeon indicated the patient was a candidate for revision.There is no evidence of a revision involving this event.Event is captured on (b)(4).Date of implantation: (b)(6) 2003.Date of revision: (b)(6) 2014 (acetabular liner and competitor femoral head) (right hip).

• Brand Name: SROM MAR LNR L 32MM+3MM 10 DEG
• Common Device Name: S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10501533
• Report Number: 1818910-2020-19494
• Device Sequence Number: 3155274
• Product Code: KWA
• UDI-Device Identifier: 10603295015918
• UDI-Public: 10603295015918
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K924492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1220-72-332
• Device Catalogue Number: 122072332
• Device Lot Number: 7831101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/08/2020
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 109