MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER IMPLANT

Catalog Number UNK SHOULDER IMPLANT

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

Patient Problems Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Date 03/28/2022

Event Type  Injury  

Event Description

It was reported that the patient tore rotator cuff muscle and converted to reverse for stability.Doi: (b)(6) 2020, dor: (b)(6) 2022, affected side: left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 4310 and 4315.H10: narrative/data was updated.One (1) imp,tsv,6.0,10,mtx,mg (tsvt6b10) was returned for investigation.Visual evaluation of the as returned product identified no malfunction.Device determined to be within specifications.The reported event is non-verifiable with the information provided and following inspection of the returned device.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported product that did or could cause or contribute to the reported event.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was likely within specification and likely conforming when it left zimmer biomet.Dhr review was completed for the subject lot number (1240895).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1240895) for similar events and no other complaint was identified utilizing keyword(s) (loss of integration perforated sinus) the reported event could not be recreated due to the nature of the dental device and event (medical conditions) and the complaint is not related to the functional performance of the product.As per the rmf rm-002w3 rev 10, the potential cause for the reported event is customer error in surgical site preparation based on implant size.A definitive root cause could not be identified.No immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: UNKNOWN SHOULDER IMPLANT
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14101541
• MDR Text Key: 289172847
• Report Number: 1818910-2022-06633
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 44; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 44X15 ECC
• Patient Outcome(s): Required Intervention
• Patient Sex: Female