MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 52; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Catalog Number	113643026
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient fell multiple times and glenoid became loose.Doi: unknown.Dor: (b)(6) 2023.Affected side: right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =according to the information received, "it was reported that the patient fell multiple times and glenoid became loose.Doi: unknown.Dor: (b)(6) 2023.Affected side: right shoulder." the product was not returned to depuy synthes, however photos were provided for review.Visual inspection of the provided photographic evidence revealed that the crosslink anchor pg glenoid 52 was explanted.Based on the provided evidence the investigation can not confirm the allegation of loosening.The device exhibits damage, most likely attributed to the extraction process.The investigation was not able to confirm the reported event.The overall complaint was unconfirmed as the observed condition of the crosslink anchor pg glenoid 52 would contribute to the complained device issue.Based on the investigation findings it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 records evaluation (mre) was not performed.
Event or Problem Description
Additional information received: a.Was there any surgical delay? what was the duration of the delay? b.It was indicated that there was glenoid loosening.On what interface did the loosening occur? c.Was there any revision surgery performed before for the multiple falls? d.Was there an allegation against the stem and the humeral head? a.No surgical delay.B.Unknown.C.No.D.No allegation against stem or head, surgeon preference to remove.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 52
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17710603
• Report Number: 1818910-2023-18325
• Device Sequence Number: 19370330
• Product Code: KWS
• UDI-Device Identifier: 10603295007012
• UDI-Public: 10603295007012
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K052472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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 Catalogue Number: 113643026
• Device Lot Number: D113787025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLOBAL ADVANTAGE HUM HD 52X18; GLOBAL ADVANTAGE STEM 12 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male